Chronopharmacology of Valsartan in Normotensive Subjects

• Status: Completed
• Trial end date: 2017-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The choice of drug administration time may affect the pharmacokinetics and/or drug response, and knowledge of any such circadian rhythm-dependent effects may help to reduce side effects or to enhance efficacy. This study designed to investigate the potential influence of the time of drug administration on the pharmacokinetics and pharmacodynamics of the valsartan in healthy subjects.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Ain Shams University
• Treatments: Valsartan

Criteria

Inclusion Criteria:

1. At least 18 years old and not more than 45 healthy male volunteers

2. Actual weight no more than ± 30% from ideal body weight based on sex, height, and body frame

3. Who had passed all the screening parameters including physical examination, laboratory tests.

4. Who had to be able to communicate effectively with study personnel, be literate, and able to give consent.

5. diurnal active subjects with eight hour night sleep.

6. free of any drug exposure known to interfere with the pharmacokinetics/pharmacodynamics or assay of valsartan for at least 10 days prior to the study

Exclusion Criteria:

1. Treatment with any known enzyme-inducing/inhibiting agents within 30 days prior to the start of the study and throughout the study.

2. Susceptibility to allergic reactions to valsartan.

3. Any prior surgery of the gastrointestinal tract that may interfere with drug absorption.

4. Gastrointestinal diseases.

5. Renal diseases.

6. Cardiovascular diseases.

7. Pancreatic disease including diabetes.

8. Hepatic diseases.

9. Hematological disease or pulmonary disease

10. Abnormal laboratory values.

11. Subjects who have donated blood or who have been involved in multiple dosing study requiring a large volume of blood (more than 500 ml) to be drawn within 6 weeks preceding the start of the study.

12. Nocturnal active subjects